to evaluate the effect of gabapentin in reducing pain and reduce the use of opioids after VATS surgery
Design
One hundred patients candidate for VATS surgery at Masih Daneshvari Hospital will included. Patients will randomly divided into two groups of control and intervention. Group allocation was concealed by assigning a unique code to each participants. Simple randomization will be used.
Settings and conduct
Masih Daneshvari Hospital, Tehran, Iran
Patients and health care providers are blinded.
Participants/Inclusion and exclusion criteria
inclusion criteria: between 18 and 65 years proper physical condition for VATS surgery
exclusion criteria: gabapentin allergy, renal failure, hepatic failure, nervous and mental disorders, history of cardiovascular surgeries, pregnant and breastfeeding women
Intervention groups
Patients will randomly divided into two groups of 50 of control and intervention. One group receives two 300mg gabapentin capsules on the night before operation and two more an hour before surgery. The control group receives two placebo capsules on the night before operation and two more an hour before surgery.
Main outcome variables
Visual Analogue Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160813029327N12
Registration date:2018-06-10, 1397/03/20
Registration timing:registered_while_recruiting
Last update:2018-06-10, 1397/03/20
Update count:0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Researcher
Expected recruitment start date
2017-11-01, 1396/08/10
Expected recruitment end date
2018-08-01, 1397/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect Of Preemptive Gabapentin On Postoperative Pain Management After VATS Surgery
Public title
Effect Of Preemptive Gabapentin On Postoperative Pain Management After VATS Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
between 18 and 65 years
proper physical condition for VATS surgery
Exclusion criteria:
gabapentin allergy
renal failure
hepatic failure
nervous and mental disorders
history of cardiovascular surgeries
pregnant and breastfeeding women
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients and health care providers will be blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Pharmaceutical Sciences
Street address
#99, Yakhchal Ave, Shariati st, tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2017-05-08, 1396/02/18
Ethics committee reference number
IR.IAU.PS.REC.1396.73
Health conditions studied
1
Description of health condition studied
Respiratory disease
ICD-10 code
J40-J47,J0
ICD-10 code description
Chronic lower respiratory diseases,Diseases of the respiratory system,Other diseases of upper respiratory tract,Other diseases of pleura
Primary outcomes
1
Description
Pain assessment
Timepoint
each 30 minutes and then 2, 4, 6, 10 and 24 hours after operation
Method of measurement
VAS technique
2
Description
opioid rate of consumption
Timepoint
up to 24 hours after operation
Method of measurement
Based on nursing chart
3
Description
ketorolac rate of consumption
Timepoint
up to 24 hours after operation
Method of measurement
Based on nursing chart
4
Description
first analgesic need time
Timepoint
first analgesic need time after surgery
Method of measurement
Based on nursing chart
Secondary outcomes
1
Description
adverse reactions
Timepoint
up to 24 hours after operation
Method of measurement
questionnaire
Intervention groups
1
Description
interventional group receives two 300mg gabapentin capsules on the night before operation and two more an hour before surgery.
Category
Prevention
2
Description
The control group receives two placebo capsules on the night before operation and two more an hour before surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Behrooz Farzanegan
Street address
Daarabad ,Niavaran , Tehran
City
tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
farzaneganbehrooz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farshad Hashemian
Street address
Yakhchal St, IAUPS
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2263 3986
Email
fhashemian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Behrooz Farzanegan
Position
Assistant professor,Anesthesiologist,Fellowship of Critical Care Medicine
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Daarabad ,Niavaran , Tehran
City
tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2537
Fax
Email
farzaneganbehrooz@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
PhD,Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy
Street address
#99, Yakhchal Ave, Shariati st, tehran ,Iran
City
tehran
Province
Tehran
Postal code
1941933111
Phone
+212 2633986
Fax
Email
r_abrishami@iaups.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Media Shamsaddini
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
#99, Yakhchal Ave, Shariati st, tehran ,Iran
City
tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 7780 7863
Fax
Email
media.1372@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available